Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy (GLOX-PEN)

AC Camargo Cancer Center

Status: Enrolling

Conditions: Oxaliplatin-induced Peripheral Neuropathy; Colon Cancer

Treatments: Device: Surgical Gloves

Study type: Interventional

Funder types: Other

Identifiers

NCT07285356

90669425.4.1001.5432

Details and patient eligibility

About

The primary objective of this randomized clinical trial is to assess whether the use of surgical gloves during treatment can prevent the occurrence of oxaliplatin-induced peripheral neuropathy.

Full description

Gastrointestinal tumors account for one-quarter of the global cancer incidence and one-third of cancer-related deaths. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of oxaliplatin-based treatments. CIPN can lead to an extremely painful and debilitating process, causing significant loss of functional abilities and negatively affecting the quality of life of these patients, as well as activities of daily living (ADLs) such as walking, buttoning clothes, writing, brushing teeth, among others. This condition can even result in a state of vulnerability, with a high risk of falls and other injuries.

Primary Objective and Study Rationale:

Oxaliplatin, widely used to treat patients with colorectal neoplasms, is associated with chemotherapy-induced peripheral neuropathy (CIPN). Given the high prevalence and negative impact of CIPN on quality of life and adherence to cancer treatment, there is a significant gap in identifying effective prevention and management strategies. Although recent evidence suggests that surgical gloves (SG) can mitigate paclitaxel-induced peripheral neuropathy, SGs have not been tested for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN). Therefore, the primary objective of this randomized clinical trial is to evaluate whether the use of SGs during treatment can prevent the occurrence of grade 2 or higher OIPN in the hands, as assessed by CTCAE v5.0 and PRO-CTCAE.

Secondary Objective:

To determine the relationship between Body Mass Index and the presence of sarcopenia, with the occurrence of OIPN; To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; To assess symptoms and functional limitations associated with OIPN using the EORTC QLQ-CIPN20 questionnaire.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older who have provided written informed consent.
• Colon adenocarcinoma with high-risk stage III (pT4pN2) or stage IV.
• Oxaliplatin-based treatment in the context of localized or metastatic disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion criteria

• Pre-existing neuropathy.
• Uncontrolled diabetes.
• known glove allergies.
• Prior treatment with paclitaxel, docetaxel or oxaliplatin.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Surgical Gloves

Experimental group

Description:

During each chemotherapy cycle, patients in the experimental arm will wear compressive surgical gloves (0.5 size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion.

Treatment:

Device: Surgical Gloves

No Surgical Gloves

No Intervention group

Description:

The control arm will receive treatment according to current recommendations without the use of any devices on the hands.